Cleared Traditional

MOST-T Autoclave (K220102) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K220102 · Shinva Medical Instrument Co., Ltd. · General Hospital
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Oct 2022
Decision
273d
Days
Class 2
Risk

K220102 is an FDA 510(k) clearance for the MOST-T Autoclave. Classified as Sterilizer, Steam (product code FLE), Class II - Special Controls.

Submitted by Shinva Medical Instrument Co., Ltd. (Zibo, CN). The FDA issued a Cleared decision on October 12, 2022 after a review of 273 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6880 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Shinva Medical Instrument Co., Ltd. devices

Submission Details

510(k) Number K220102 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 2022
Decision Date October 12, 2022
Days to Decision 273 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
144d slower than avg
Panel avg: 129d · This submission: 273d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FLE Sterilizer, Steam
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6880
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Consultant

Guangzhou Osmunda Medical Device Technology, Inc.
Olivia Meng

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FLE Sterilizer, Steam

All 61
Devices cleared under the same product code (FLE) and FDA review panel - the closest regulatory comparables to K220102.
PRIMUS Healthcare Sterilizer (Model PSS11-HC)
K221474 · Primus Sterilizer Company, LLC · Feb 2023
Steelco VS Series Steam Sterilizers, models 262839, 262851, 262869
K213545 · Steelco S.P.A. · Feb 2023
Tuttnauer Pre-vacuum Steam Sterilizer models 3870HSG and 3870HSG-WS
K222608 · Tuttnauer , Ltd. · Dec 2022
Tuttnauer Horizontal autoclave series model: 4472, 5596, 6690, 66120
K221227 · Tuttnauer , Ltd. · Sep 2022
Lexa PLUS RIS-311
K213758 · W&H Sterilization S.R.L. · Aug 2022
Consolidated HC Steam Sterilizer
K220736 · Consolidated Machine Corp. · Aug 2022